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Rotavirus Vaccine Ready for Rollout in India

NEW DELHI—In the United States, rotavirus is a public health nuisance, resulting in tens of thousands of hospitalizations for severe diarrhea in infants and young children each a year, but few deaths. In India, the virus is a public health menace: It claims more than 100,000 lives a year. A new vaccine could sharply reduce that death toll.

At a press conference here today, K. Vijayraghavan, secretary of the Department of Biotechnology, announced that a vaccine against the predominant rotavirus strain circulating in India had compiled an "excellent safety and efficacy profile" in phase III clinical trials. ROTAVAC, the first fruits of the Indo-U.S. Vaccine Action Program, is expected to be on the market in early 2014. But some experts caution that the vaccine will not be a panacea. "It is unlikely that a single Indian strain of the virus will provide immunity to children all over India, since there is so much genetic variation in the rotavirus," says Jacob Puliyel, a pediatrician at St. Stephen's Hospital in New Delhi.

Rotavirus spreads easily through contaminated food and water; some 20 million children in India are infected every year. The virus causes severe diarrhea, often accompanied by vomiting and fever; most deaths are from dehydration in children who are not given treatment or inadequately treated by India's frail health care system.

Hope for an Indian vaccine against rotavirus was born in 1985, when Maharaj Kishan Bhan, a vaccine researcher then at the All India Institute of Medical Sciences here identified a nonpathogenic strain of the virus. The vaccine effort gained momentum 13 years later, when the Indo-U.S. Vaccine Action Program selected a young pharmaceuticals company in Hyderabad, Bharat Biotech Ltd., to develop and manufacture the vaccine. Since then, the Indian government and foreign partners, including the Bill & Melinda Gates Foundation, have poured about $100 million into the project.

In the phase III trial, 4532 newborns received ROTAVAC. Compared with a control group, the vaccine reduced severe diarrhea by 56% during the first year of life. The successful trial results are "a significant victory for India's scientific community," said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, in a statement. (A partner in the collaboration, NIAID provided the strain tested in the ROTAVAC trial.) It was the first phase III efficacy trial conducted in India for any vaccine, notes Bhan, who adds that the vaccine should save tens of thousands of lives and $100 million a year in hospitalization costs. ROTAVAC's price is expected to be set at $1 per dose, and it will be administered as a series of three oral doses. That's almost 40 times cheaper than a pair of Western-manufactured vaccines now on the market in India.